PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)— 510(k) K123902

Name: FDA 510(k) clearance K123902
Creator: U.S. Food and Drug Administration
Published: 2013-09-13

Substantially Equivalent

Oktx, LLC

FDA 510(k) clearance K123902 for PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S), Substantially Equivalent on 2013-09-13. Applicant: Oktx, LLC. Device class: 2.

Clearance details

Applicant: Oktx, LLC
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2012-12-18
Decision date: 2013-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.